[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78256-78257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31387]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0360]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Public Health Notification Readership Survey (Formerly
Known as the Safety Alert/Public Health Advisory Readership Survey)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by January
14, 2011.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or e-mailed to [email protected]. All
comments should be identified with the OMB control number 0910-0341.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850. 301-796-3793.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Food and Drug Administration Public Health Notification Readership
Survey (Formerly Known as the Safety Alert/Public Health Advisory
Readership Survey)--(OMB Control Number 0910-0341)--Reinstatement
Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 375(b)) authorizes FDA to disseminate information concerning
imminent danger to public health by any regulated product. The Center
for Devices and Radiological Health (CDRH) communicates these risks to
user communities through two publications: (1) The Public Health
Notification (PHN) and (2) the Preliminary Public Health Notification
(PPHN). The PHN is published when CDRH has information or a message to
convey to health care practitioners in order for them to make informed
clinical decisions about the use of a device or device type when that
information may not be readily available to the affected target
audience in the health care community. CDRH can make recommendations
that will help the health care practitioner mitigate or avoid the risk.
The PPHN is also published when CDRH has information to convey to
health care practitioners in order for them to make informed clinical
decisions about the use of a device or device type. However, two
additional conditions exist that make use of this type of notification
preferable: (1) CDRH's understanding of the problem, its cause(s), and
the scope of the risk; the Center believes that health care
practitioners need the information they can provide, however
incomplete, as soon as possible, and (2) the problem is actively being
investigated by the Center, private industry, another Agency, or some
other reliable entity, so that the Center expects to be able to update
the PPHN when definitive new information becomes available.
Notifications are sent to organizations affected by risks discussed in
the notification, such as hospitals, nursing homes, hospices, home
health care agencies, retail pharmacies, and other health care
providers. Through a process for identifying and addressing postmarket
safety issues related to regulated products, CDRH determines when to
publish notifications.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. FDA seeks to evaluate the clarity, timeliness, and impact
of safety alerts and public health advisories by surveying a sample of
recipients.
Subjects will receive a questionnaire to be completed and returned
to FDA. The information to be collected will address how clearly
notifications for reducing risks are explained, the timeliness of the
information, and whether the reader has taken any action to eliminate
or reduce risks as a result of the information in the alert. Subjects
will also be asked whether they wish to receive future notifications
electronically, as well as how the PHN program might be improved.
The information collected will be used to shape FDA's editorial
policy for the PHN and PPHN. Understanding how target audiences view
these publications will aid in deciding what changes should be
considered in their content and the format and method of dissemination.
In the Federal Register of August 24, 2009 (74 FR 42674), FDA
published a 60-day notice requesting comments. No comments were
received. However, FDA is republishing this 30-day notice for public
comment, due to the amount of time that has passed for submission of
this information collection request to OMB.
FDA estimates the burden of this collection of information as
follows:
[[Page 78257]]
Table 1--Estimated Annual Reporting Burden \1\
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Annual
Public Health Service Act section Number of frequency per Total annual Hours per Total hours
respondents response responses response
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1701(a)(4)......................................................... 308 3 924 0.17 157
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the PHN program, it is estimated that an
average of three collections will be conducted a year. The total burden
of response time is estimated at 10 minutes per survey. This was
derived by CDRH staff completing the survey and through discussions
with the contacts in trade organizations.
Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31387 Filed 12-14-10; 8:45 am]
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